Sampling in the Pharmaceutical Industry
There are several sampling processes associated with pharmaceutical manufacturing, whether during the production of active pharmaceutical ingredients (ingredient reaction, powder analysis) or during the production of pharmaceutical end products (characterization of raw materials, water quality, or finished product quality). Reliable analytical tools are essential at all stages of the process.
Control and identification of raw materials
The various drug and health product regulatory agencies emphasize many quality standards that must be met by the raw materials found in pharmaceuticals. Frequent sampling is therefore required in order to comply with current regulations.
Facility cleanliness
Our bags facilitate the monitoring workflow in glove boxes in purified neutral gas, which are essential for delicate operations. They provide an airtight environment where contaminants are removed, preserving the integrity of the substances handled. These strict precautions are essential to ensure the quality and success of projects in these sensitive environments.
Water quality control
Water for pharmaceutical use meets high quality requirements, whether it is used as a product component or during production, and the bacterial load must be regularly monitored. Chemical-physical and microbiological quality controls are therefore essential for production in accordance with the standards defined in pharmacopoeias.
Applications
Reliable and safe sampling tools are essential in order to carry out the various tests and analyses required within this industry.
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Analysis of active ingredients
Pharmaceuticals are subject to strict rules regarding the concentration of active ingredients. Their content and quality play a major role in the safety and efficacy of the tested drug. The results achieved must meet the standards set by the various drug and health product regulatory agencies.
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Biocontamination assessment and control
Sterile or non-sterile preparation production areas must undergo microbiological contamination control. A rigorous sampling plan is required to ensure adequate follow-up and to meet current standards.
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Finished product sampling
Finished product testing is necessary to ensure that the finished product meets the specifications for identification, assay, purity, microbiological quality and other specified characteristics.
The LABPLAS advantage
Doing business with LABPLAS ensures you quality products and a service adapted to your needs.
Guaranteed sterility
LABPLAS products are sterile, either by the very process of extrusion or by irradiation. The sterility of the manufactured bags is checked periodically by periodically sampling and analyzing the different production lines.
ISO 9001:2015 certified company
LABPLAS is ISO 9001:2015 certified, which demonstrates our commitment to meeting and exceeding industry standards. Our adherence to this quality standard guarantees the quality and reliability of your products. Compliance of your products is guaranteed for all future orders.
Traceability of our products
You will always have access to all information about your LABPLAS products (traceability number for each batch of product, production date, sterility guarantee, etc.) thanks to the sterility certificate included with each order.